1. Field of the Invention
The present invention relates generally to surgical implants for treating incontinence or other surgical conditions, and more particularly, to centering aids used in conjunction with such implants to assist in proper placement of the implant.
2. Background Discussion
Female stress urinary incontinence (SUI) is a medical condition commonly associated with weakening of the pelvic muscles and/or connective tissues that support the urethra in its proper position. As a result, involuntary urine leakage occurs from simple physical activity, such as running or jumping, and even coughing or sneezing, as the urethra is not properly supported and does not remain fully closed during such activity.
A widely accepted medical procedure to correct SUI is the insertion of a tension-free, trans-vaginal tape that is surgically implanted in the pelvic tissue and that extends under and provides support for the urethra when pressure is exerted thereon. U.S. Pat. No. 5,899,909, the disclosure of which is incorporated herein by reference, describes in detail a typical procedure for treating SUI using a trans-vaginal tape. The tape is implanted by passing an elongated curved needle that is attached to one end of the tape through an incision in the vaginal wall, to one lateral side of the urethra, through the pelvic tissue behind the pubic bone, and exiting out through an incision made in the abdominal wall. The procedure is repeated for the other end of the mesh tape, this time on the other lateral side of the urethra, with the needle exiting through a second incision made in the abdominal wall of the patient. After the mesh tape is properly adjusted relative to the urethra, the free ends that extend outside of the abdominal wall are trimmed. Over time, fibroblasts grow into the mesh tape to anchor the tape in the surrounding tissue. Thus, the tape is left as an implant in the body to form an artificial ligament supporting the urethra in order to restore urinary continence. In another known method for implanting a trans-vaginal tape, the tape is inserted in a somewhat similar manner, but is brought out through the obturator foramen and exits the body through a small incision in each upper leg. Such a method is described in detail in U.S. Pat. No. 7,611,454 which is incorporated herein by reference in its entirety.
Following introduction of the trans-vaginal tapes described above, shorter length slings have been developed that do not require the entire tape to be passed out through secondary external incisions in the abdomen or upper leg, and that leave less foreign material behind within the body. One such device is described in detail in U.S. Pat. No. 7,601,118, which is incorporated herein by reference in its entirety. For these “mini” slings that do not exit the body, unless the mesh is properly centered there can be no guarantee that the respective ends of the sling extend far enough into the proper tissue, such as the obturator membranes, to ensure sufficient tissue ingrowth and resulting stabilization of the tape, as the ends of the tape are not visible to the surgeon.
To address this problem, some slings have been known to use a marker, such as a line or different color, at the mesh center as an indicator for proper positioning. Such a mark, however, is often difficult or impossible to see when the tape is deployed in the surgical incision due to the surrounding blood and tissue, particularly if it is moved slightly off center at any time.
Thus, there is a need for an improved implant including a device for assisting in its proper placement.